Method for protecting personal information

ABSTRACT

It is an objective of the present invention to provide a method capable of protecting personal information.  
     A method for protecting personal information that can be obtained by analyzing a biological sample is provided, wherein the method comprises adding to the biological sample a component obstructing the analysis of another component that provides personal information to be protected. Thus, the analysis of personal information such as genomic information without the person&#39;s consent can be technically prevented.  
     In addition, the present invention provides a technique for not only simply protecting personal information, but also for analyzing the once protected personal information as needed.

TECHNICAL FIELD

[0001] The present invention relates to a method for protecting personalinformation such as genetic information.

BACKGROUND ART

[0002] Each individual's genetic information recorded on genomic DNA isretained in the form of DNA. Such information is output via RNA asfunctional molecules such as proteins. Therefore, all geneticinformation may be regarded as having a chemical form, and at the sametime, being an information medium. Although genetic information is notan electronic digital signal, a system for maintaining the security ofthat information is important when it comes to its safe maintenance.

[0003] Most organisms convert all the genetic information of eachindividual into a database and maintain that information within cells inchemical, molecular forms called genes. Genetic information is extractedfrom the database in the form of RNA anytime as needed, thus maintainingthe activities supporting life. In multicellular organisms, every one ofthe cells constituting an individual, retains all the information of thewhole individual in the form of genomic DNA. That is to say, anindividual has as many copies of the database as the number of cellsconstituting the individual. Due to the presence of a great number ofcopies of information, maintaining the security poses an extremelydifficult problem.

[0004] Among information retained in genomic DNA, there are many piecesof information requiring security. Currently, human genomic DNAs arebeing sequenced. The genetic information on genomic DNA naturally variesgreatly between species, but there are also many slight differences evenamong individuals of the same species. Such differences are expressed asbiological properties (phenotypes) of each individual. Phenotypesranging from life span to a risk for contracting a specific disorder,and also as far as certain personalities, are said to be influenced bygenomic DNA. Such genetic predispositions may have a great socialsignificance in some cases, and hence, such information requires a highlevel of security. For example, personal information on a geneticpredisposition of having a high risk of contracting a disease should notbe easily accessible to a third party.

[0005] Gradual elucidation of the genome structure is expected to leadto an increase in genetic information analysis. As a result, geneticinformation requiring secure maintenance is likely to continue to rise.Therefore, a technique capable of preventing the analysis of geneticinformation recorded in genomic DNA is important.

[0006] There are many pieces of important information not only ingenomic DNA information, but also in personal information that can beelucidated by analyzing biological samples. For example, it is generallyprohibited by law to test whether an individual is infected by aspecific virus without the consent of that individual. If suchinformation is allowed to be readily made public, the individual islikely to undergo social discrimination regardless of his or herpersonality or will. Therefore, the provision of a technique capable ofmanaging information derived from biological samples is useful.

[0007] Despite the essential necessity for a security system foractively preventing the leakage of such personal information encoded byDNA or RNA or in other chemical molecular forms, no effective means forthat purpose is available yet. There are many techniques for maintainingthe security of genetic information obtained by analyzing eachindividual's DNA or RNA that have already been converted into electronicdigital signals. Such electronic information can be controlled by acentralized management using a computer. However, it is impossible tomaintain the security of information recorded as chemical substancessuch as DNA by using management techniques for electronic information,because the information source is held in cells constitutingindividuals. A large number of gene copies exist in a single individual,and, moreover, blood cells, mucous cells and the like can be readilycollected. Furthermore, since techniques for culturing these harvestedcells and amplifying genes are available, it may be impossible tomaintain the information security on a cell unit level.

[0008] As a result, at present, information security is barelymaintained solely by the rule or morale that tests are not to beconducted without a person's consent. Therefore, it is an importantobjective to provide a technique capable of more securely maintainingthe security of such information that can be obtained from a livingorganism. Nowadays, when the genomic draft has already been revealed andthe post-sequencing era is coming around the corner, the protection ofgenetic information is likely to become an extremely important issue.

DISCLOSURE OF THE INVENTION

[0009] It is an objective of the present invention to provide a methodcapable of protecting personal information, more specifically, atechnique enabling the maintenance of the security of personalinformation that can be obtained by analyzing biological samples such ascells.

[0010] The present inventors thought that it would be possible toimprove the security of a large amount of information, including geneticinformation, if the analysis of personal information conducted withoutinformed consent can be technically prevented. In other words, theythought that what was needed for the safe maintenance of information wasnot systems that depend on social security maintenance systems such asrules, morals, and such, but a way to technically prevent the analysisof information. The inventors actively pursued studies on techniquescapable of effectively preventing the analysis of biological samples,accomplishing the present invention. That is, the present inventionrelates to a method for protecting personal information and applicationsthereof as described below:

[0011] [1] A method for protecting personal information obtained byanalyzing a biological sample, wherein said method comprises adding tothe biological sample, a component that obstructs the analysis ofanother component that provides personal information to be protected.

[0012] [2] The method according to [1], wherein said personalinformation to be protected is genetic information.

[0013] [3] The method according to [2], wherein said component thatprovides genetic information is a nucleic acid or a protein.

[0014] [4] The method according to [3], wherein said nucleic acid isgenome or mRNA.

[0015] [5] The method according to [4], wherein said componentobstructing analysis is a DNA comprising a region having a nucleotidesequence that provides personal information.

[0016] [6] The method according to [5], wherein said nucleotide sequencethat provides personal information contains a mutation.

[0017] [7] The method according to [4], wherein said componentobstructing analysis is at least one of the DNA analysis obstructersselected from the group consisting of:

[0018] (a) a random primer,

[0019] (b) an inhibitor of the DNA-polymerase reaction,

[0020] (c) an inhibitor of nucleic acid synthesis, and

[0021] (d) a nuclease.

[0022] [8] A method for analyzing personal information protected by themethod according to [1], wherein said method comprises the step ofremoving the obstruction of the component that was added to obstruct theanalysis.

[0023] [9] The method according to [8], wherein said obstructingcomponent is DNA, and wherein the method comprises the step of removingthe obstruction of the DNA by selective separation, decomposition, ormodification thereof.

[0024] [10] The method according to [9], wherein the method comprisesthe step of selectively separating said DNA by the affinity binding to atag added in advance to the DNA.

[0025] [11] The method according to [10], wherein said tag is anaffinity binding substance and/or an artificially added nucleotidesequence.

[0026] [12] The method according to [9], wherein said obstructingcomponent is DNA comprising a restriction enzyme recognition sequencethat is not present in the nucleotide sequence to be analyzed, andwherein said method comprises the step of removing the obstruction byreacting with a restriction enzyme to selectively decompose the DNA.

[0027] [13] The method according to [8], wherein said method comprisesthe steps of:

[0028] (a) adding to a biological sample a DNA comprising (i) anucleotide sequence that provides personal information and (ii) amutation as the component that obstructs the analysis,

[0029] (b) analyzing the nucleotide sequence that provides personalinformation of a nucleic acid contained in said biological sample usinga primer and/or probe, wherein said primer and/or probe is capable ofhybridizing to the nucleic acid derived from the biological sample, butthe hybridization to the DNA added in step (a) is inhibited due to themutation contained in said DNA, and

[0030] (c) analyzing personal information contained in the nucleic acidderived from the biological sample using the hybridization level of saidprobe and/or primer as an index.

[0031] [14] A kit for analyzing protected personal information, whichcomprises a means for removing the obstructing action of the componentadded to obstruct the analysis.

[0032] [15] A biological sample-collecting vessel for protectingpersonal information obtained by analyzing a biological sample, whereinsaid vessel is filled in advance with a component that obstructs theanalysis of another component that provides the personal information tobe protected.

[0033] [16] The vessel according to [15] provided with a means forindicating that the analysis of the component that provides personalinformation to be protected has been obstructed.

[0034] [17] The vessel according to [15] further provided with a meansfor indicating information necessary for removing said obstruction.

[0035] [18] The vessel according to [17], wherein said indication hasbeen encoded.

[0036] [19] A database that connects (a) biological sample-collectingvessels for protecting personal information that can be obtained byanalyzing a biological sample, wherein the vessels are filled in advancewith a component that obstructs the analysis of another component thatprovides personal information to be protected, and (b) a means necessaryfor removing the influence of said obstructing component for each of thevessels.

[0037] [20] A method for protecting personal information, wherein themethod comprises the steps of:

[0038] (1) connecting (a) biological sample-collecting vessels forprotecting personal information that can be obtained by analyzing abiological sample, wherein the vessels are filled in advance with acomponent that obstructs the analysis of another component that providespersonal information to be protected, with (b) a means necessary forremoving the influence of said obstructing component for each of thevessels, and

[0039] (2) disclosing, according to a request from an individual whorequires analysis, a means necessary for removing the influence of saidobstructing component for a specific vessel.

[0040] [21] A sample-analyzing device provided with the following means:

[0041] a) a means for reading an indication on a biologicalsample-collecting vessel that (a) is equipped with a means forindicating information capable of specifying the vessel, and

[0042] (b) is a biological sample-collecting vessel for protectingpersonal information obtained by analyzing a biological sample, whereinsaid vessel is filled in advance with a component that obstructs theanalysis of another component that provides personal information to beprotected,

[0043] b) a means for disclosing a means necessary for removing theinfluence of an obstructing component contained in said vessel byinquiring the database according to [19] about information capable ofspecifying the vessel,

[0044] c) a means for implementing the means disclosed by the means ofb) that is necessary for removing the obstruction, and

[0045] d) a means for analyzing the biological sample.

[0046] [22] The device according to [21], which comprises inquiring thedatabase according to [19] about information capable of specifying avessel via a network.

[0047] [23] A test sample-analyzing device equipped with the followingmeans:

[0048] a) a means for reading an indication on a biologicalsample-collecting vessel equipped with a means for indicatinginformation necessary for removing the influence of an obstructingmeans, wherein said vessel for protecting personal information that canbe obtained by analyzing a biological sample has been filled in advancewith a component that obstructs the analysis of another component thatprovides personal information to be protected,

[0049] b) a means for implementing a means necessary for removing theobstruction based on information read in step a), and

[0050] c) a means for analyzing the test sample.

[0051] [24] The analytical device according to [23], which comprises ameans for decoding the encoded information necessary for removing theinfluence of said obstruction means.

[0052] [25] The analytical device according to [24] comprising a meansfor inquiring about information necessary for the decoding via anetwork.

[0053] [26] A method for analyzing a biological sample, wherein themethod comprises:

[0054] a) reading an indication on a vessel for collecting a biologicalsample equipped with a means for indicating information capable ofspecifying said vessel for protecting personal information obtained byanalyzing a biological sample, wherein said vessel has been filled inadvance with a component that obstructs the analysis of anothercomponent that provides personal information to be protected,

[0055] b) disclosing a means necessary for removing the influence of aobstructing component contained in said vessel by inquiring the databaseaccording to [19] about information capable of specifying the vessel,

[0056] c) implementing the means necessary for removing the obstructionbased on the information read in step b), and

[0057] d) analyzing the sample.

[0058] [27] A method for analyzing a biological sample, wherein themethod comprises:

[0059] a) reading an indication on a biological sample-collecting vesselequipped with a means for indicating information necessary for removingthe influence of an obstructing means, wherein said vessel forprotecting the personal information obtained by analyzing saidbiological sample has been filled in advance with a component thatobstructs the analysis of a component that provides the personalinformation to be protected,

[0060] b) implementing a means necessary for removing the obstructionbased on the information read in step a), and

[0061] c) analyzing the sample.

[0062] A biological sample as referred to in the present invention meansall kinds of samples that can be analyzed, which are obtained fromliving organisms and contain chemical substances that provideinformation on the organism. Normally, biological samples can beobtained by collecting tissues and body fluids constituting the body orexcrements of an organism. Tissues may be derived from every organ,skin, mucous membrane, hair, tooth, nail, etc. Examples of body fluidsare blood, sperm, mucus, digestive fluids such as saliva, bile, gastricjuice, and the like. Furthermore, among excrements, sweat, feces, urine,and the like, are used as biological samples.

[0063] In the present invention, a chemical substance that providesinformation on a living organism refers to a chemical substance whoseanalysis provides some sort of information on the organism. Herein, achemical substance means a substance having a molecular form. Therefore,a variety of organic compounds including nucleic acids and proteins areall chemical substances regardless of whether the structure and functionhave been elucidated or not. On the other hand, information that hasbeen once analyzed and recorded in electronic media is not included inthe chemical substances of the present invention.

[0064] A chemical substance that provides information on an organism isa substance whose analysis provides some sort of information on theorganism. Analysis of a chemical substance as described in the presentinvention refers to acquiring information on the chemical substancederived from the above-described biological sample using any artificialmethod and converting the information to a manageable state. In otherwords, this analysis is an act that converts information held in thechemical substance into a form other than the original form. Morespecifically, analysis of a chemical substance can be defined aselucidating the physicochemical properties of the chemical substanceitself, or the presence (absence) or the amount thereof.

[0065] Herein, the presence (absence) of a substance includes not onlythe presence (absence) of the substance at the time of analysis, butalso the case of proving a trace of its presence (absence) in the past.In general, analysis of a substance means the analysis of the structureor presence of the substance, or the amount present, or such, but is notlimited to these. More specifically, a biological sample generallycomprises substances ranging from genomic DNA to RNA, proteins, variousmetabolites produced as a result of metabolisms by enzyme proteins,foreign compounds ingested by the individual and their metabolites, etc.All of these chemical substances can provide diverse pieces ofinformation through the analysis of those substances. Personalinformation as used in the present invention is information that can beobtained by analyzing a biological sample, which is information on theliving organism from which the biological sample derived from.

[0066] Hereinbelow, the process of decoding the genetic information willbe described when the genetic information of a biological sample is DNAand RNA. First, normally, the amplification of only the necessarygenetic information by PCR is required. PCR is performed using DNAextracted from a biological sample as a template or after converting anextracted RNA into DNA using reverse transcriptase. Using DNA fragmentsamplified by PCR, genetic information is analyzed. Examples ofanalytical methods are nucleotide sequence analysis of DNA and RNA,various electrophoretic methods (SSCP method, DNA finger printingmethod, RFLP method, etc.), methods based on hybridization to DNA, RNA,or PNA probes having a specific nucleotide sequence, methods usingmicroarray such as DNA chips, methods using precise molecular weightmeasurement with mass spectrometry, methods based on techniques foranalyzing bimolecular interactions, such as weight measurement usingsurface plasmon resonance, calorie meters, or quartz oscillators.

[0067] Alternatively, there are a number of analytical techniques basedon principles different from that of the PCR method, such as the RCA(rolling circle amplification) method. The method for analyzing SNPs bythe RCA method is well-known in the art. Furthermore, as a nucleicacid-analyzing technique based on a principle different from that of thePCR method, the NASBA method targeting RNA for analysis has been put topractical use. Furthermore, a method such as the SDA method foranalyzing nucleic acids is also well-known in the art as a techniquebased on a principle different from that of PCR method. Although all ofthese analytical methods are different from the PCR method in thereaction principle, these methods and PCR are common in using nucleicacid synthetases such as DNA and RNA polymerases.

[0068] Furthermore, in the case of using a protein derived from abiological sample as a test sample for decoding genetic information,examples of analytical methods are: methods for analyzing the amino acidsequence of a target protein; methods for analyzing amino acidcomposition; immunological analytical methods using the antigen-antibodyreaction; analytical methods using various chromatographies; analyticalmethods utilizing microarrays using protein chips; analytical methodsbased on precise molecular weight measurement by mass spectrometry;analytical methods using a technique for analyzing bimolecularinteractions such as the weight measurement using surface plasmonresonance, calorie meters, quartz oscillators, etc.

[0069] Chemical substances, and information that can be obtained by theanalysis thereof, will be more specifically described hereinbelow.Nucleic acids are important as chemical substances holding geneticinformation. The form of variations in the genetic information for eachindividual as described in the present invention includes: differencesdue to single nucleotide substitutions in genomic DNA [Single NucleotidePolymorphisms (SNPs)]; differences due to the substitution of onenucleotide or more; frameshifts due to the insertion and deletion ofnucleotides; differences in the repeating number of tandemly repeatedsequences (variable number tandem repeat (VNTR)); deletions,duplications, and inversions of specific DNA regions; segmentation ofgenetic information due to the insertion of transposons, viruses, etc.;and the like. These variations induce differences in the properties ofeach individual. There are two types of such variations, one type beingcongenital while the other type appears as a variation in geneticinformation in certain cells in the form of a postnatal mutation.Postnatal mutagenesis is a major cause for serious disorders such ascancer. In addition, genetic information such as microsatellite markersthat can be used as indexes for specific genetic characteristics is alsoimportant.

[0070] It is also possible to obtain, from a sample collected from aliving body, not only genetic information on the living organism itself,but also information on other living organisms that are infecting (orparasitic on) this living body. For example, the detection of a virusgenome in a body fluid of a living body provides evidence of a virusinfection. Furthermore, if the genetic information of a pathogenicbacterium is detected in the feces and urine, it will be evidence of abacterial infection. When these facts of infection are required to bemanaged as information, the genetic information providing the evidencebecomes personal information that should be protected by the presentinvention.

[0071] In the present invention, the protection of personal informationis achieved by adding to the biological sample a component thatobstructs the analysis of a chemical substance that provides personalinformation to be protected. In other words, aiming at protectinginformation, this invention is established by intentionally obstructingthe analysis of a chemical substance that provides information. Theanalysis of various chemical substances has shown the presence ofcomponents that obstruct the analysis. However, no technique thatintentionally obstructs the analysis aiming at the protection ofpersonal information was known. In the present invention, theachievement of the protection of a particular information by obstructingthe analysis of a chemical substance is called “locking.”

[0072] Furthermore, in this invention, the recovery of a once obstructedanalysis to an analyzable state by any means is termed “unlocking.”Locking can be achieved, for example, by techniques such as interferingwith analytical results, obstructing the reaction of analysis, removingor decomposing a chemical substance to be analyzed, and so on.Protection of personal information can be achieved by locking.Therefore, a method for protecting personal information in the presentinvention aims at achieving the locking of information, regardless ofwhether the unlocking is possible or not.

[0073] However, in a specific embodiment of the present invention, theunlocking of information is also possible. That is, this inventionprovides a method for analyzing personal information that has beenprotected by the above-described means, in which the method comprisesthe step of removing the obstruction of the aforementioned componentthat has been added for obstructing the analysis. For example, when thelocking is achieved by interfering with analytical results orobstructing the reaction of analysis, the unlocking can be realized byremoving the cause of the locking. More specifically, the locking andthe unlocking can be achieved, for example, by the following techniques.When the decoding of personal information is irreversibly locked, thislocking is not required to be unlocked. However, by making the unlockingpossible, it is possible, for example, to allow only a specificauthorized organization to decode the personal information. Furthermore,this unlocking enables flexible operation of the information managementsystem in that it allows the analysis of information with a personalauthorization as a prerequisite. Alternatively, the unlocking systemmakes it possible to respond in emergency situations when the analysisof information must take precedence over an individual's wish.

[0074] A method for protecting personal information by obstructing theanalysis of a gene represented by genomic DNA using the gene as achemical substance will be specifically described hereinbelow. Geneticvariations for each individual are recorded (encoded) on genomic DNA inthe form of nucleotide sequences. Furthermore, a portion ofinformation-read from the genomic DNA is encoded in RNA. Analysis isperformed by artificially decoding the information encoded in these DNAand RNA. Nowadays, the analyses of DNA or RNA are mostly carried out byusing their annealing to probes and/or primers, the enzymatic reactionwith DNA or RNA polymerases, etc. Therefore, if it were possible toobstruct these reactions themselves or interfere with analyticalresults, it would be possible to obstruct the analysis of the DNA orRNA. In the present invention, a component capable of obstructing DNAanalysis is termed a DNA analysis obstructer.

[0075] Locking genetic information with dummy DNA

[0076] It is possible to lock information by artificially adding anucleic acid such as DNA or RNA to a biological sample. In the presentinvention, such artificially added nucleic acids are generically calleddummy DNAs.

[0077] A dummy DNA to be added may comprise a wild-type nucleotidesequence or a plurality of genetic variations. Furthermore, a dummy DNAhaving a nucleotide sequence that should not normally exist may be alsoadded. In general, the more variations a dummy DNA has, the moresecurely the obstruction of gene analysis can be achieved. It isdesirable to add a dummy DNA in an amount that exceeds the amount of DNApresent in the individual from which the biological sample is derived.For example, when nucleic acid molecules comprising a plurality ofnucleotide sequence types are artificially added as dummy DNA, they areexcessively added so that the total amount of the added dummy DNAexceeds that of the presumed total nucleic acid molecule amountcontained in the biological sample. An excessive amount refers to atleast an amount that is equal to, or more than, preferably two folds ormore of, the amount of the gene in the test sample, where the gene isthe object of analysis. In the case of using a dummy DNA to obstructPCR, which may be referred to as the essential reaction for geneanalysis at present, it is particularly effective to add an excessivedummy DNA amount of three-folds or more.

[0078] When DNA is extracted from a biological sample, purified andsubjected to decoding, dummy DNAs completely conceals the DNA of theindividual from whom the biological sample derived. When amplifying DNAby PCR in particular, dummy DNAs are dominantly amplified and locks theoriginal information. Even if the decoding of genetic information isdone without the help of the PCR amplification process, the presence ofa dummy DNA in an excess amount will establish the locking ofinformation. That is, the dummy DNA interferes with the DNA informationof an individual from whom the biological sample derived, making thedecoding of genetic information impossible, resulting in the locking ofgenetic information by the dummy DNA.

[0079] In one case, a dummy DNA may contain all the genetic information,whereas in another, it may contain, depending on the purpose, only asingle or several specific pieces of genetic information. Whencontaining all of the information, every information derived from thebiological sample will be locked, while, in the case of containingmerely a portion of genetic information, only the portion of informationwill be locked. That is, it is possible to selectively lock the geneticinformation to be locked according to the purpose.

[0080] It is desirable that a dummy DNA is structurally similar to thenucleic acid that is the object of analysis. Alternatively, the dummyDNA may be of the same species. For example, genomic DNA may be used forobstructing genome analysis, and RNA for obstructing RNA analysis. Morespecifically, to obstruct human genomic DNA analysis, the human genomecan be used as a dummy DNA. As to human genomic DNA, when aiming atobstructing the analysis in a specific chromosome, a specific chromosomeor fragments thereof may be added, or one or more sets of chromosomesmay be used as dummies. In addition, when aiming at obstructing RNAanalysis, it is also effective to use dummy RNA, or cDNA that will bedefinitely synthesized in the process of RNA analysis. In this case, asa dummy RNA, RNA obtained by in vitro synthesis using DNA as a template,or a natural RNA extracted from living cells, can be used.

[0081] Locking genetic information by a random primer

[0082] In contrast to confusing templates in a locking method by theaddition of dummy DNA, a random primer may be added aiming at confusingprimers. In contrast to a dummy DNA that achieves the locking of aparticular gene analysis, locking by a random primer can be said to be atechnique for locking the extraction of a particular genetic informationby inhibiting gene amplification from a specific primer in PCR.

[0083] In the present invention, when nucleic acids such as dummy DNAsand random primers are used to obstruct gene information analysis, thesenucleic acids can be added to biological samples in the form of asolution or a solid. In this case, locking of genetic information can beeasily achieved by using a sample-collecting tool or vessel into which adummy DNA has been filled in advance. To protect nucleic acids such asdummy DNAs, and the like, from the degradation action of nucleases andsuch, the dummy DNA may be enclosed in a protecting material.

[0084] More specifically, a dummy DNA can be protected by enclosing itin microcapsules, liposomes, macromolecules such as gels, etc. As aprotecting material used in this invention, by selecting a materialhaving a property that will be lost when cells are disrupted to extractDNA or RNA in order to release the enclosed dummy DNA, the obstructingaction of the dummy DNA can be expressed at the instance of geneticinformation analysis. Examples of protecting materials satisfying suchconditions are liposomes, microcapsules, etc.

[0085] Liposomes can be prepared, for example, by mixingphosphatidylcholine, phosphatidylglycerol, cholesterol, and such atappropriate weight ratios, followed by dispersing the resulting mixturein an aqueous solution of dummy DNA, etc. Furthermore, microcapsulesmade of agarose beads, mixtures of alginic acid and calcium, and thelike, are well known. Methods for enclosing DNA or RNA in theseprotecting materials are also well known in the art. In the presentinvention, not only protecting materials, but also drugs, nucleaseinhibitors, and such can be combined for stabilizing dummy DNA.

[0086] Locking method using a DNA polymerase inhibitor

[0087] As described above, at present, DNA and RNA polymerases can besaid to be principle enzymes in gene analysis. They are importantenzymes constituting a number of gene analytical techniques such as thePCR method, RCA method, NASBA method, SDA method, and the like.Therefore, mixing inhibitors of these enzymes in advance with abiological sample can interfere with gene analysis. As an enzymeinhibitor, an antibody against the enzyme, a chelating reagent, aprotease that digests the enzyme protein, and the like, can be used.

[0088] The Method for irreversibly decomposing a component that is theobjective of analysis, or converting the component into a state that isimpossible to analyze

[0089] In the case where the unlocking of information is not intended,information can be locked by irreversibly decomposing the chemicalsubstance that is the objective of analysis, or converting the substanceinto a state that cannot be analyzed. For example, genetic informationcan be made unanalyzable by decomposing the DNA with a digestive enzymesuch as a nuclease. Since RNA in particular is easily decomposed byRNase, the enzymatic degradation thereof is effective as a technique forlocking information.

[0090] Furthermore, compounds irreversibly inhibiting the synthesis of anucleic acid by decomposing it, binding to it, or chemically modifyingit, for example by alkylation, are also effective in lockinginformation. As a compound of this type, a nucleic acid-targetingantibiotic can be used. More specifically, such compounds areexemplified by mitomycin, actinomycin, bleomycin, cisplatin, theirderivatives, and the like. Furthermore, compounds such as nitrogenmustard and N-methyl-N′-nitrosoguanidine and the like can be used ascompounds that inhibit the synthesis of nucleic acids by acylationthereof.

[0091] All the compounds cited so far are those that can lockinformation when they are mixed with biological samples. In contrast, acompound capable of locking information only under a specific conditioncan be also used in the present invention. For example, compounds suchas the triphenanthroline-ruthenium complex, triphenanthroline-cobaltcomplex are known to show DNA cleavage activity when exposed to light.Furthermore, psoralen and derivatives thereof can be given as substancesthat inhibit the synthesis of DNA by binding thereto as a result ofbeing exposed to light. The use of such compounds that are activated byexposure to light makes it possible to control the locking ofinformation by light exposure. Therefore, for example, information canbe locked by shading the system containing compounds such as thosedescribed above until the test is over and then exposing it to light.

[0092] Alternatively, it is also possible to lock information usingcompounds that react with DNA under heat. For example, after treatingDNA in a biological sample with dimethyl sulfate, formic acid, sodiumhydroxide, potassium permanganate, or such, piperidine is added, and theresulting mixture is heated at 90° C. for 30 min, or at a temperaturelower than 90° C. for a long time, to cleave DNA and RNA, therebyinhibiting the synthesis.

[0093] In addition, a technique for inhibiting nucleic acid synthesis bya physical action can be used to lock information. For example,ultrasonic sound and irradiation of ultraviolet rays or radiationenables one to cleave nucleic acids so as to inhibit synthesis thereof.

[0094] These analysis-obstructing components or means can be used aloneor in combination. By combining a plurality of obstructive actions toprovide various obstructions, illegal analyses can be more surelyprevented.

[0095] As already described, in a specific embodiment of the presentinvention, it is possible to unlock a biological sample that is in alocked state that resulted due to an obstruction of analysis. Anembodiment in which the unlocking can be conducted will be specificallydescribed hereafter. The unlocking can be achieved by removing ordecomposing a substance that has been added to obstruct analysis, or byattenuating the obstructive action of the substance.

[0096] For example, when obstructing analysis with a dummy DNA, thisdummy DNA can be removed or the obstructive action thereof can beattenuated by various methods. An example of a technique that enablesthe unlocking is, modifying the dummy DNA with a compound and removingthe dummy DNA from the biological sample using this modifying compound(modifier). When obstructing analysis with a dummy DNA that functions asa template, the dummy DNA can be modified using any substance at anyposition, as long as the resulting modified dummy DNA can act as atemplate. Furthermore, in the case where dummy DNA acts as a primer, itcan be modified with any substance at any position except for the 3′-endof the molecule.

[0097] By contacting the modified dummy DNA with a substance havingaffinity to the modifier, dummy DNA can be selectively absorbed andremoved. Such a modifier is exemplified by a substance having a bindingactivity towards the affinity compound. More specifically, compoundssuch as biotin, digoxigenin, lectin, and the like, are known to have abinding activity towards their respective affinity substances. DummyDNAs labeled with these compounds can be removed from a biologicalsample as described below.

[0098] That is, first, this affinity substance is added to DNA or RNAthat has been extracted and purified from a biological sample. The useof an affinity substance that has been immobilized in advance on acarrier such as beads, or something that can be immobilized, makes theseparation of dummy DNA easy. Dummy DNA binds to the affinity substanceand precipitates in the solution. The precipitate is separated from thesupernatant by centrifugation, or such, and removed. Dummy DNA can bealmost completely removed by conducting this separation once to severaltimes.

[0099] Furthermore, when the affinity substance is an antibody, it maybe used as it is. In this case, using beads and the like on which asubstance (e.g., protein A, protein G, etc.) having an affinity to theantibody is immobilized, the substance and the whole antibody boundthereto can be trapped and precipitated. By the above-describedoperation, the dummy DNA is removed from the DNA or RNA derived from thebiological sample enabling the following PCR and decoding of its geneticinformation.

[0100] Even when a dummy DNA is modified with a plurality of compounds,it is possible to unlock information by repeating the above-describedoperation using affinity substances corresponding to each of thecompounds. In the present invention, the unlocking can be achieved evenwhen the dummy DNA is not completely removed. As shown in Examples,locking of genetic information by dummy DNA can be achieved more surelywhen the dummy DNA is present in as much amount as possible relative tothe living organism-derived genetic material contained in the sample. Inother words, the unlocking can be achieved if it is possible to create asituation in which dummy DNA is present only in a small amount relativeto the amount of genetic information derived from the living organism.However, since genetic material deriving from a biological sample maynot always be present in a sufficiently large amount, it is needless tosay that the removal of dummy DNA as completely as possible is anessential condition for surely unlocking information.

[0101] When the removal of dummy DNA is made possible by absorption of amodifier, needless to say, information as to what the modifier is, mustbe strictly controlled. Leakage of this type of information may resultin the undesirable unlocking of information by a third party.Furthermore, it is possible to make the illegal unlocking by a thirdparty more difficult by mixing with several types of dummy DNAs modifiedby different compounds.

[0102] A dummy DNA can be removed not only through the binding of amodifier compound to an affinity substance, but also by hybridization.Hereinbelow, a method of incorporating into dummy DNA a specificnucleotide sequence for hybridization is described. DNAs bind topolynucleotides having complementary nucleotide sequences by hydrogenbonds. This binding can be made specific to a nucleotide sequence byperforming hybridization under highly stringent conditions. Therefore,the addition to a dummy DNA a nucleotide sequence that is not present ina nucleic acid containing the genetic information to be analyzed, makesit possible to specifically remove the dummy DNA by hybridization. Inthis case, the probe used for removing the dummy DNA is bound in advanceto a solid phase, or to a tag that can be trapped by a solid phase, andthereby, the dummy DNA is easily removed.

[0103] It is possible to unlock dummy DNA by a technique other than themodification thereof. Hereinbelow, a method for positioning a specificrestriction enzyme recognition site in a dummy DNA will be described asan unlocking technique that does not rely on modification. For example,when information on gene A is the object of analysis, DNA having anucleotide sequence similar to that of gene A is used as a dummy DNA. Anarrangement of a restriction enzyme recognition site in the dummy DNAmakes it possible to specifically cleave the dummy DNA by a restrictionenzyme. The restriction enzyme used in this case is one that recognizeslong nucleotide sequences which comprise, for example, six or morenucleotides, and which are clearly not present in gene A, the object ofanalysis. For example, when a biological sample that has already beenlocked is treated with a restriction enzyme prior to PCR, the dummy DNAis not amplified, but only the genetic substance derived from the livingorganism is. In the method using restriction enzymes, it is notnecessary to chemically modify dummy DNA, which makes it easy to preparethe dummy DNA. Furthermore, when it is so arranged that the unlockingcannot be conducted unless a plurality of restriction enzymes are used,the certainty of information locking can be enhanced.

[0104] In this case, fragments of dummy DNA digested with a restrictionenzyme have the restriction enzyme recognition sequence at the 3′-end.This results in dummy DNA fragments having nucleotide sequencesdifferent from those of the genetic substances derived from the livingorganism. When a primer is not completely complementary to a template atthe 3′-end, it is understood that usually, such ends do not becomereplication origins for polymerases. Therefore, the possibility of thedigested dummy DNA fragment acting as a primer and thus failing toachieve the unlocking is low.

[0105] To achieve the unlocking, it is also possible to use a probeand/or primer whose hybridization to dummy DNA is inhibited. That is,the present invention relates to a method of analyzing protectedpersonal information, wherein the method comprises:

[0106] (a) adding to a biological sample a DNA comprising (i) anucleotide sequence that provides personal information and (ii) amutation as the component that obstructs the analysis,

[0107] (b) analyzing the nucleotide sequence that provides personalinformation of a nucleic acid contained in said biological sample usinga primer and/or probe, wherein said primer and/or probe is capable ofhybridizing to the nucleic acid derived from the biological sample, butthe hybridization to the DNA added in step (a) is inhibited due to themutation contained in said DNA, and

[0108] (c) analyzing personal information contained in the nucleic acidderived from the biological sample using the hybridization level of saidprobe and/or primer as an index.

[0109] In this method, as a dummy DNA, a DNA that comprises a nucleotidesequence corresponding to the sequence providing personal information,but also has a mutation therein is used. There is no limitation in thesite and the number of mutations in the dummy DNA. A DNA havingmutations in at least 1, usually 2 to 4, preferably 5 to 20 or 20 to 50sites can be used as the dummy DNA. Sites of mutation may be consecutiveor far apart. A dummy DNA having a plurality of mutations in a regionlikely to provide personal information to be protected, may be asuitable DNA in the present invention.

[0110] A region likely to provide personal information to be protectedmay be exemplified first by a region that will become the object foranalyzing a polymorphism or mutation. Furthermore, in the presentinvention, a region to which a primer used for amplifying these objectsanneals, is also included in the region likely to provide personalinformation to be protected. Primers are designed using a nucleotidesequence that flanks the objective region and is expected tospecifically amplify such a region. Therefore, in general, a primer usedfor amplifying a particular region is often selected from a certainrange on a target nucleotide sequence. Therefore, once the region likelyto provide personal information is identified, it is possible to predicta region to which a primer necessary for analyzing that region anneals.Alternatively, DNA chips are expected to be used for the analysis. Inthis case, a DNA having a mutation in a region that will become thetarget of the DNA that is likely to be used as a probe in a DNA chip, ispreferable as a dummy DNA.

[0111] A dummy DNA, when analyzed by a usual analytical technique,interferes with the analytical results of nucleic acids derived from theliving organism so as to protect personal information. To carry out theanalysis of personal information derived from the biological samplewithout being influenced by dummy DNA, key primers or key probes areused in the present invention. A key primer refers to a primer that iscapable of functioning as a primer for DNA derived from the livingorganism, but is incapable of doing so for dummy DNA due to the mutationin the dummy DNA. Such a primer can be obtained, for example, bysynthesizing an oligonucleotide comprising a nucleotide sequence sodesigned that the 3′-end of the primer is arranged to correspond to themutation of the dummy DNA. The use of a key primer enables the specificsynthesis of nucleic acids derived from the biological sample. Since itis impossible to design the nucleotide sequence of a key primer withoutknowing the exact site of mutation in the DNA added as the dummy DNA,the unlocking using the key primer is achieved.

[0112] Hereinbelow, a method for amplifying only a target DNA derivedfrom a biological sample by PCR using a key primer will be described indetail. In this case, a mutation by a single nucleotide substitution ofa predetermined nucleotide in the dummy DNA sequence is inserted inadvance so that the dummy DNA differs from DNA derived from thebiological sample. Thus, all dummy DNAs are different from DNA derivedfrom the living organism at this mutation site in the nucleotidesequence. As shown in the example of FIG. 10, dummy DNAs have guanine(G) (FIG. 10, dummy DNA-1), adenine (A) (FIG. 10, dummy DNA-2), orthymine (T) (FIG. 10, dummy-3) at the site that generally has cytosine(C) in the DNA derived from the living organism. When using a PCR primerwhose 3′-end is capable of annealing to the aforementioned nucleotideportion, a mismatched base pair is formed between this primer and thedummy DNA at the 3′-end, making the amplification by PCR difficult.However, this primer completely anneals to the DNA derived from theliving organism without forming mismatched base pairs, and thus, onlythe DNA derived from the living organism can be amplified. Such a primeris referred to as a key primer, and it is impossible to selectivelyamplify DNA derived from a living organism without knowing the sequencesof the two key primers that anneal to the upstream and downstream of theDNA region to be amplified.

[0113] If a number of point mutations are inserted into dummy DNAs tomake them different from the DNA derived from a living organism, it isnot easy to detect which mutations are common to all dummy DNAs.Therefore, for example, in the case of amplifying a target DNA of 1,000bp, 200,000 or more different combinations of primers have to be testedto find the two key primers, making the search for them difficult.

[0114] Furthermore, key probes refer to, similar to key primes, DNAscomprising a nucleotide sequence which is capable of hybridizing to aDNA derived from a living organism, but the hybridization to dummy DNAis inhibited because of the mutation in the dummy DNA. Analysis using aDNA chip is conducted based on signal intensity compared to that of amismatched probe (probe having a single base difference). That is,analysis is performed under conditions where the difference in onenucleotide can be distinguished as a difference in signal intensity.Therefore, using a key probe according to the present invention, it ispossible to distinguish the signal of a dummy DNA having a singlenucleotide difference from the signal of DNA derived from a livingorganism. This way, only a DNA chip containing the key probe cancorrectly analyze the locked biological sample. Thus, it is possible tounlock the information by the key probe.

[0115] It is also possible to obtain genetic information of a livingorganism not only from nucleic acids, but also from translation productsthereof, namely, proteins. In some cases, mutations in the nucleotidesequence of a gene can be found by analyzing the amino acid sequence ofthe protein. Furthermore, it is also possible to find whether or not aprotein has a particular mutation by analyzing the immunologicalreaction between the protein and an antibody, or a biological activityof the protein. Thus, chemical substances in the present invention thatprovide personal information to be protected include proteins.

[0116] When a protein derived from a biological sample is used to decodegenetic information, it is possible to use a dummy protein to lockinformation, as in the case of nucleic acids. Since dummy proteinsinclude wild type proteins and various mutant proteins, they areindistinguishable from proteins derived from the biological sample.Thus, it is impossible to extract only the information deriving from thebiological sample.

[0117] Furthermore, it is possible to unlock information by removing adummy protein using a method similar to that for dummy DNA. That is, theunlocking can be achieved by chemically modifying a dummy protein inadvance using a modifier, and adding a substance having a specificaffinity to that modifier to remove the dummy protein. As a dummyprotein, a fusion protein to which a specific protein has been added mayalso be used. Fusion proteins can be easily obtained by a geneticengineering technique. When a protein added to form a fusion protein isan antigenic substance, it is possible to remove the dummy protein usingan antibody recognizing this antigenic substance. Alternatively, if themodifier is a metallic ion affinity protein such as a histidine tag, itcan be absorbed with a nickel column, or such. Alternatively, it is alsopossible to position beforehand, a specific protease-recognizing aminoacid sequence in the amino acid sequence of a dummy protein toenzymatically decompose the protein.

[0118] In the present invention, to lock information that can beobtained from a protein, the analysis can be obstructed by modifying ordenaturing the protein. Techniques for modifying and denaturing proteinsare well known in the art. For example, proteins can be denatured byheat-treating a biological sample-containing protein. Furthermore, byreacting a protease with a biological sample, the protein is randomlydigested so that the amino acid sequence becomes impossible to beanalyzed.

[0119] The above-described technique using dummy molecules that can beapplied to lock and unlock information derived from DNAs, RNAs, orproteins of living organisms, is applicable to all molecules containedin living organisms. Thus, it is also possible to control theacquisition of information of living organisms by measuring metabolites,hormones, enzyme activities, etc.

[0120] Reagent components necessary for a method based on this inventionfor analyzing protected personal information can be supplied as a kitassembled in advance. That is, the present invention provides a kit foranalyzing protected personal information, which comprises a means forremoving the obstruction of a component added to obstruct the analysis.The above-described means may be a single means, or a combination ofseveral means. When the treatment for removing the obstruction can beconducted in a homogeneous system, a plurality of means may be combinedto form a kit of the present invention. In the kit of the presentinvention, reagents necessary for analysis can be combined as needed.

[0121] For example, when a dummy DNA modified with an affinity substanceis added, a kit comprising the binding partner for the affinitysubstance can be used. This kit may include a primer necessary forconducting the objective analysis. As described above, information canbe effectively locked by using a combination of several compounds asaffinity substances. To unlock information thus locked, a reagentcomprising a combination of several binding partners is required.

[0122] To deal with such a situation, preparing a kit comprising inadvance all required combinations of binding partners for unlockingreagents that can respond to various combinations of affinitysubstances, is important. A kit according to the present inventioncomprising a combination of binding partners may be given any nameaccording to the combinations. The name of the kit is so arranged thatthe binding partner(s) constituting the kit cannot be predicted from thename. In this case, unlocking can be permitted by simply specifying thename of the kit necessary for the unlocking, without specifying the typeof affinity substance modifying the dummy DNA used for locking. A thirdparty cannot specify the binding partner necessary for the unlockingsolely from the name of a kit. As a result, the security of personalinformation can be enhanced by controlling the distribution of the kitand information contained therein.

[0123] That is, the present invention relates to a kit that comprisesseveral means for removing the obstruction of a component added toobstruct the analysis, and in which is set up several means constitutingdifferent combinations of the several means for removing theobstruction.

[0124] Alternatively, when DNA with a mutation is added as a dummy DNA,a kit comprising a key probe and/or key primer is used. In this case,the key primer and/or key probe, function as a means for removing theaforementioned obstruction, and at the same time, acts as a reagentnecessary for conducting the objective analysis.

[0125] In the present invention, depending on the nucleotide sequence ofthe dummy DNA added to protect personal information, the sequences ofthe key primer and/or key probe needed for the unlocking vary.Therefore, for example, by setting up a plurality of dummy DNA sets inadvance, it is possible to prepare a kit comprising combinations of DNAsnecessary to cover all possible combinations of key primers and/or keyprobes corresponding to the sets of the dummy DNAs. Similarly as in theprevious example, it is possible to specify a key primer necessary forunlocking by referring to the name of kit used for the unlocking.

[0126] Herein, cells collected from a living organism function not onlyas a sample containing genetic information, but also as a data source ofgenetic information. Therefore, for example, it is possible to producecopies of genetic information by culturing collected cells.Alternatively, prior to performing the decoding process, it is alsopossible to culture cells in a biological sample, proliferate them, andthen extract the genetic information from the cultured cells. Therefore,in order to control genetic information, the prevention of culturingonce the cells are collected, is also an important issue. For thatpurpose, a drug capable of killing the collected cells, or reversiblyblocking the physiological activity thereof, may be added. The presentinvention also includes the locking by drugs to block the physiologicalactivity of cells. Locking of genetic information by dummy DNAs, DNApolymerase inhibitors, and such, would most likely be inadequate forcertain cell cultures. Therefore, the prevention of cell culture iseffective in locking information.

[0127] For example, respiratory enzyme inhibitors and variousantibiotics can be used to block the physiological activity of cells.Specifically, the addition of antibiotics and respiratory enzymeinhibitors that do not act on nucleic acids enables the irreversibleblocking of the physiological activity of cells. As an antibiotic thatdoes not act on nucleic acids, for example, Kanamycin, or derivativesthereof, can be used. Alternatively, as a respiratory enzyme inhibitor,cyanides are well known. Drugs that irreversibly block the physiologicalactivity of cells will continue to inhibit cell culture, even after thecells are separated, and thus, a more secure locking of information canbe expected. On the other hand, drugs that reversibly block thephysiological activity of cells are useful in that they make unlockingof information possible by separating cells.

[0128] It is desirable to add these drugs to biological samples atsufficiently high concentrations so as to achieve a sure effect.Specifically, in the case of blocking the physiological activity ofblood cells such as lymphocytes, and the like, using, for example,potassium cyanide as a drug, it is added to a final concentration of atleast 1 μM or more, usually in the range of 5 to 500 μM. In practice, itis convenient to fill in advance, tools and vessels for collectingbiological samples with these drugs at a concentration capable ofachieving a sufficient action according to the expected amount ofsamples.

[0129] A biological sample is generally collected to obtain some sort ofinformation. Therefore, it is desirable to prevent the analysis ofgenetic information based on the present invention, and, at the sametime, not influence the necessary test as much as possible. For example,since the addition of dummy DNA is unlikely to influence most enzymaticreactions, it is a suitable technique for locking genetic information inthe present invention. Nowadays, many biochemical tests of serum lipids,enzymes in blood, and such, are conducted based on enzymatic reactions,and such enzyme reactions are thought to be hardly influenced by nucleicacids in general.

[0130] The method for protecting personal information according to thepresent invention can be easily carried out by using a sample-collectingvessel that has been filled in advance with a component for obstructingthe analysis. For example, blood-collecting vessels are commerciallyavailable. Such commercially available blood-collecting vessel arenowadays filled in advance with a variety of drugs such as serumseparators, anticoagulants, glycolysis inhibitors, and the likeaccording to the purpose for collecting blood. In addition to thesedrugs, a component that obstructs the analysis in the present inventionmay also be filled into the vessels. Using such vessels, the samplecollection and personal information locking can be simultaneouslyachieved.

[0131] When a component for obstructing the analysis of a component thatprovides personal information to be protected is added to a biologicalsample based on the present invention, the fact that the component wasadded may be indicated depending on the need. Especially, when theunlocking of information is required, it is useful to indicate what sortof blocking has been done. However, needless to say, the indicationshould not be made in a form that makes the illegal unlocking by a thirdparty easy. For example, when the dummy DNA is removed by the bindingthereof to an affinity substance, the fact of locking may be indicatedby a code that implies the affinity substance that has to be used forthe unlocking.

[0132] In the present invention, there is no limitation in the types ofmeans for indicating information on a sample-collecting vessel.Indication of information includes, for example, the printing ofinformation directly on a sample vessel, pasting of a label on whichinformation is printed, attachment of a magnetic medium in whichinformation is recorded, etc. Furthermore, information may be indicatednot only directly on the sample vessel itself, but also indirectly.Indirect indication of information includes, for example, indicatinginformation on the rack that holds sample vessels, or on lids and coversof the vessels. Therefore, it is also possible to indicate informationon the rack, and also specify each sample-collecting vessel by where itis arranged on the rack. Furthermore, information in the presentinvention includes not only lettered information, but also informationthat is distinguished by symbols and/or colors, or shapes, colors ormaterials of sample vessels, as well as the lids.

[0133] Furthermore, the present invention relates to a databasecorrelating a biological sample-collecting vessel for protectingpersonal information obtained by analyzing a biological sample, whereinsaid vessel is filled in advance with a component that obstructs theanalysis of another component that provides the personal information tobe protected, with a means necessary for removing the influence of saidobstructing component for each of the vessels. Database refers to amedium maintaining information in a machine-readable state, or a systemthat can be referred to as needed for information. Database of thepresent invention can be used by an organization that manufactured thebiological sample-collecting vessels (containing a component thatobstructs analysis based on this invention) to protect personalinformation, for the purpose of controlling a means necessary to performaccurate analysis without being influenced by the obstructing componentfor each of the vessels. Once a sample vessel is specified, informationnecessary for analysis can be obtained by referring to this database.

[0134] The Database is controlled by the organization that manufacturedthe biological sample-collecting vessels. The vessels are maintained soas not to disclose their contents unrestrictedly to the public. A thirdparty who wants to analyze a biological sample in a sample-collectingvessel, can obtain necessary information by inquiring such anorganization about information necessary for the analysis, or asking forpermission to use the database as needed.

[0135] Database of the present invention can store together not onlyinformation necessary for conducting analysis without being influencedby an obstruction, but also information to assess the analytical result.Specifically, for example, in the case of disclosing information onprimers for PCR, the length of the nucleotide sequence to be synthesizedby said primers and number of nucleotide bands can be provided.

[0136] In the present invention, a means necessary for removing theinfluence of the above-described obstructing component for each vesselrefers to the aforementioned means for unlocking. More specifically, themeans can be exemplified by information specifying primers and DNA chipsfor PCR necessary for the accurate analysis or information required forremoving the obstructing component. Information on primers, chips, andthe like, which can be described in nucleotide sequences, can bedirectly disclosed. Alternatively, necessary information can bedisclosed by specifying a particular nucleotide sequence out of acollection of predetermined nucleotide sequences.

[0137] Furthermore, not only nucleotide sequences, but also variousconditions for performing more appropriate reactions can be alsodisclosed together. A more proper analysis can be done by unifyingdiverse conditions that are likely to influence the reaction intoconditions that are hardly susceptible to the influence of theobstructing component.

[0138] Furthermore, the present invention provides a method forprotecting personal information, wherein the method comprises the stepsof:

[0139] (1) connecting (a) biological sample-collecting vessels forprotecting personal information that can be obtained by analyzing abiological sample, wherein the vessels are filled in advance with acomponent that obstructs the analysis of another component that providespersonal information to be protected, with (B) a means necessary forremoving the influence of said obstructing component for each of thevessels, and

[0140] (2) disclosing, according to a request from an individual whorequires analysis, a means necessary for removing the influence of saidobstructing component for a specific vessel.

[0141] Step (1) can be carried out, for example, by preparing theaforementioned database. Furthermore, in the present invention, a personin need of analysis refers to a subject from whom the biological samplehas been collected, or an analysis organization that has been permittedby such a subject to do the analysis. Therefore, step (2) includes astep of certifying whether or not the person in need of analysis isactually the person to whom the disclosure of analytical conditions hasbeen permitted. The certification step can be conducted, for example,using a certification code previously set up for each subject. Morespecifically, the certification can be performed using a password set upby the subject himself.

[0142] Furthermore, according to the present invention, a method foranalyzing a biological sample is provided, wherein the method comprises:

[0143] a) reading an indication on a vessel for collecting a biologicalsample equipped with a means for indicating information capable ofspecifying said vessel for protecting personal information obtained byanalyzing a biological sample, wherein said vessel has been filled inadvance with a component that obstructs the analysis of anothercomponent that provides personal information to be protected,

[0144] b) disclosing a means necessary for removing the influence of aobstructing component contained in said vessel by inquiring the databaseabout information capable of specifying the vessel,

[0145] c) implementing the means necessary for removing the obstructionbased on information read in step b), and

[0146] d) analyzing the sample.

[0147] In the present invention, information capable of specifying avessel may be, for example, the manufactured lot number, or a number orsymbol unique to each sample vessel. In the case where the specificationrelies on a lot number, it discloses to users an unlocking techniquecommon to all the products within the same lot. Therefore, a more firmsecurity can be expected by giving an indication unique to each vessel.

[0148] An indication specifying a vessel can be conferred by knowntechniques such as printing of letters, colors, symbols or bar-codes orusing magnetic media, etc. These indications can be mechanically read.

[0149] Information necessary for analysis can be obtained by inquiringthe above-described database about it based on the content of theindication means. Based on the information thus obtained, the analyticalmethod of the present invention is carried out by implementing a meansnecessary for removing the obstruction and further analyzing the sample.In the present invention, the step of implementing a means necessary forremoving the obstruction is, for example, the step of selecting primersrequired for analysis to make preparations for the analysis reaction.Once the preparation is completed, analysis can be carried out accordingto the usual analytical method. A series of such steps can be automatedby an apparatus.

[0150] That is, the present invention relates to a sample-analyzingdevice provided with the following means:

[0151] a) a means for reading an indication on a biologicalsample-collecting vessel that (a) is equipped with a means forindicating information capable of specifying the vessel, and (b) is abiological sample-collecting vessel for protecting personal informationobtained by analyzing a biological sample, wherein said vessel is filledin advance with a component that obstructs the analysis of anothercomponent that provides personal information to be protected,

[0152] b) a means for disclosing a means necessary for removing theinfluence of an obstructing component contained in said vessel byinquiring the database about information capable of specifying thevessel;

[0153] c) a means for implementing the means disclosed by the means ofb) that is necessary for removing the obstruction, and

[0154] d) a means for analyzing the biological sample.

[0155] In the apparatus according to the present invention, theabove-described database can be locally maintained by the apparatus, orthe apparatus can inquire the database-controlling organization via anetwork. An organization that controls a database is, for example, anabove-described organization that manufactured a sample vessel of thepresent invention. Alternatively, a duplicate of the database preparedby such an organization can be stored in a predetermined secondorganization. A database is so controlled that only a certifiedapparatus is permitted to refer to it. Thereby, security is maintainedeven when the database is mechanically referred.

[0156] The apparatus according to the present invention has a means forconducting a means necessary for removing the obstruction revealed bythe means of b). The means c) includes, for example, a means forselecting appropriate primers necessary for PCR analysis and givingdirections to the operator. Alternatively, it can be so designed thatthe apparatus initiates analysis by automatically selecting anappropriate primer(s) out of a plurality of primer sets previously setin the apparatus.

[0157] An embodiment of the protection of personal information and theuse thereof based on the present invention is shown in FIG. 13, which isa schematic representation of the system constitution as describedbelow. First, the “organization for protecting and controlling personalgenome information” maintains information on sample-collecting vesselsthat have been filled in advance with a component that obstructsanalysis, and, for each vessel, information on an analyticaltechnique(s) that is not influenced by the obstructing component.Institutions entrusted with clinical tests, such as medical institutionsand clinical test firms may know of the obstruction of geneticinformation analysis in the sample-collecting vessels. However, theyhave no information on how an unobstructed analysis can be conducted.Therefore, when the analysis of a sample is needed in a medicalinstitution or an institution entrusted with clinical tests, they canrequest the “organization for protecting and controlling personal genomeinformation” to disclose the information necessary for analysis with theconsent of the individual who has provided the sample. In FIG. 13, thisprocess is conducted through communication between the “geneticinformation analysis device with a security function” and databasemaintained by the “organization for protecting and controlling personalgenome information”. A network connects both systems. First, the“genetic information analysis device with a security function” specifiesthe sample collecting vessel whose analysis has been directed, andrequests the database maintained by the “organization for protecting andcontrolling personal genome information” to disclose the information(unlocking code) necessary for analyzing the sample collected in thevessel. The database system maintained by the “organization forprotecting and controlling personal genome information” disclosesinformation necessary for the analysis after authorization by the“genetic information analysis device with a security function” accordingto the demand. The “genetic information analysis device with a securityfunction” can proceed with the analysis of the sample based on theunlocking code thus disclosed under unobstructed conditions.

[0158] The patient who has provided a sample can permit the analysisthereof only to a specified “genetic information analysis device with asecurity function.” Therefore, for example, even when the biologicalsample leaks out, accurate analysis cannot be conducted. Furthermore,for medical institutions and institutions entrusted with clinical testswho actually analyze the sample, no particular procedure to protectpersonal information is required since information necessary forobtaining the right result is automatically received by communicationsbetween the above devices. Therefore, the management of a large quantityof samples is not a big burden to these organizations.

[0159] In the present invention, information necessary for removing theinfluence of an obstructing means may be indicated directly on asample-collecting vessel. That is, the present invention relates to amethod for analyzing biological samples, in which the method comprises:

[0160] a) reading an indication on a biological sample-collecting vesselequipped with a means for indicating information necessary for removingthe influence of an obstructing means, wherein said vessel forprotecting the personal information obtained by analyzing saidbiological sample has been filled in advance with a component thatobstructs the analysis of a component that provides the personalinformation to be protected,

[0161] b) implementing a means necessary for removing the obstructionbased on the information read in step a), and

[0162] c) analyzing the sample.

[0163] For example, the indication on a vessel of a symbol thatspecifies primers necessary for analysis will allow users to know theseprimers. When a plurality of primer sets exist, the right primers cannotbe selected unless the primer set corresponding to the sample vessel canbe specified. Thus, a certain level of security can be expected.Furthermore, security can be further improved by encoding theindication. When the indication itself has been encoded, it is possibleto even indicate the nucleotide sequence of primers necessary foranalysis on the vessel.

[0164] The present invention also provides an analysis apparatus capableof carrying out the aforementioned analytical method. That is, thisinvention relates to a sample analysis apparatus provided with thefollowing means:

[0165] a) a means for reading an indication on a biologicalsample-collecting vessel equipped with a means for indicatinginformation necessary for removing the influence of an obstructingmeans, wherein said vessel for protecting personal information that canbe obtained by analyzing a biological sample has been filled in advancewith a component that obstructs the analysis of another component thatprovides personal information to be protected,

[0166] b) a means for implementing a means necessary for removing theobstruction based on information read in step a), and

[0167] c) a means for analyzing the test sample.

[0168] When the information necessary for removing the influence of theabove-described obstructing means has been encoded, it is also possibleto incorporate a means for decoding such codes into the apparatus ofthis invention. Alternatively, a means for inquiring via a network aboutinformation necessary for decoding such a code may be combined in theapparatus.

[0169] A means for analyzing a sample in such an apparatus refers to asystem necessary for analyzing ordinary biological samples.Specifically, for example, the apparatus that aims to analyze nucleicacids may be provided with a mechanism for extracting a nucleic acidfrom blood cells, mixing the sample with necessary reagents to performPCR, and analyzing results thus obtained. The apparatus according to thepresent invention may be provided with a mechanism for recordinganalytical results. Since the analytical method of this invention aimsat protecting personal information, it is desirable to record analyticalresults only after encoding them.

BRIEF DESCRIPTION OF THE DRAWINGS

[0170]FIG. 1 is a photograph representing the amplification results fora ras gene fragment. Lane 1 shows the bands of DNA molecular weightmarkers, and lanes 2 and 3 represent amplification results without andwith the addition of a dummy DNA, respectively.

[0171]FIG. 2 represents analytical results of the nucleotide sequence ofthe fragment amplified using as the template, DNA derived from bloodcontaining no dummy DNA. At each fluorescence intensity peak, therespective nucleotide analyzed from the peak is described. In thepolymerase chain reaction (PCR) for the nucleotide sequence analysis,primer F was used.

[0172]FIG. 3 represents analytical results of the nucleotide sequence ofthe fragment amplified using as the template, DNA derived from bloodcontaining dummy DNA. At each fluorescence intensity peak, therespective nucleotide analyzed from the peak is described. In thepolymerase chain reaction (PCR) for the nucleotide sequence analysis,primer F was used.

[0173]FIG. 4 represents analytical results of the nucleotide sequence ofthe fragment amplified using as the template, DNA derived from bloodfrom which the added dummy DNA has been removed using streptavidin-boundmagnetic beads. At each fluorescence intensity peak, the respectivenucleotide analyzed from the peak is described. In the polymerase chainreaction (PCR) for nucleotide sequence analysis, primer F was used.

[0174]FIG. 5 represents analytical results of the nucleotide sequence ofthe fragment amplified using as the template, DNA derived from blood towhich a dummy DNA (equal amount) has been added. At each fluorescenceintensity peak, the respective nucleotide analyzed from the peak isdescribed. In the polymerase chain reaction (PCR) for nucleotidesequence analysis, primer F was used.

[0175]FIG. 6 represents analytical results of the nucleotide sequence ofthe fragment amplified using as the template, DNA derived from blood towhich a dummy DNA (3.5-fold excess) has been added. At each fluorescenceintensity peak, the respective nucleotide analyzed from the peak isdescribed. In the polymerase chain reaction (PCR) for nucleotidesequence analysis, primer F was used.

[0176]FIG. 7 represents analytical results of the nucleotide sequence ofthe fragment amplified using as the template, DNA derived from blood towhich a dummy DNA (3.5-fold excess) has been added. At each fluorescenceintensity peak, the respective nucleotide analyzed from the peak isdescribed. In the polymerase chain reaction for nucleotide sequenceanalysis, primer F was used.

[0177]FIG. 8 represents analytical results of the nucleotide sequence ofthe fragment amplified using as the template, DNA derived from blood towhich a dummy DNA has been added. At each fluorescence intensity peak,the respective nucleotide analyzed from the peak is described. In thepolymerase chain reaction (PCR) for nucleotide sequence analysis, primerD was used.

[0178]FIG. 9 represents the analytical results of the nucleotidesequence of the fragment amplified using as the template, DNA derivedfrom blood, from which the added dummy DNA has been removed usingprotein G-Sepharose. At each fluorescence intensity peak, the respectivenucleotide analyzed from the peak is described. In the polymerase chainreaction (PCR) for nucleotide sequence analysis, primer F was used.

[0179]FIG. 10 is a schematic representation of the mechanism of theselective amplification of DNA derived from a living organism using akey primer.

[0180]FIG. 11 is an electrophoretogram representing the result of theselective amplification of wild type DNA using a key primer.

[0181]FIG. 12 represents the analytical result of the nucleotidesequences of amplified DNAs shown in FIG. 11. At each fluorescenceintensity peak, the respective nucleotide analyzed from the peak isdescribed.

[0182]FIG. 13 is a diagram describing the mechanism of protectingpersonal information and utilizing the protected information based onthe present invention.

BEST MODE FOR CARRYING OUT THE INVENTION

[0183] Hereinbelow, the present invention will be specifically describedwith reference to Examples.

EXAMPLE 1 Interfering With Oncogene Ras Detection Using Blood-collectingTubes Containing Dummy DNAs

[0184] Blood-collecting tubes into which any one of eight types of dummyDNAs had been added in advance and dried up were prepared. These DNAscomprise the region of 128 bp containing a portion of the c-Ki-ras gene,one of the proto-oncogenes, having the sequences set forth in theattached sequence listing. Each of the dummy DNAs is altered in any oneof the nucleotides at the positions 68 to 70 of the DNA fragment(underlined section encoding the 61^(st) codon of the Ras protein) fromthose of a normal healthy subject [wild type (WT)]. Nucleotidesdifferent from those of WT are described in capital letters in thesequence listing. Furthermore, in the sequences other than that of WT(SEQ ID NO: 1), the 61^(st) amino acid encoded by that sequence areshown in parenthesis. (WT) 5′ ttcctaca ggaagcaagt agtaattgat ggagaaacctgtctcttgga SEQ ID NO: 1 tattctcgac acagcaggtc  aagaggagta cagtgcaatgagggaccagt acatgaggac tggggagggc tttctttgtg (Lys) 5′ ttcctaca ggaagcaagtagtaattgat ggagaaacct gtctcttgga SEQ ID NO: 2 tattctcgacacagcaggtA aagaggagta cagtgcaatg agggaccagt acatgaggac tggggagggctttctttgtg (Glu) 5′ ttcctaca ggaagcaagt agtaattgat ggagaaacct gtctcttggaSEQ ID NO: 3 tattctcgac acagcaggtG aagaggagta cagtgcaatg agggaccagtacatgaggac tggggagggc tttctttgtg (Arg) 5′ ttcctaca ggaagcaagt agtaattgatggagaaacct gtctcttgga SEQ ID NO: 4 tattctcgac acagcaggtc Gagaggagtacagtgcaatg agggaccagt acatgaggac tggggagggc tttCtttgtg (Pro) 5′ ttcctacaggaagcaagt agtaattgat ggagaaacct gtctcttgga SEQ ID NO: 5 tattctcgacacagcaggtc Cagaggagta cagtgcaatg agggaccagt acatgaggac tggggagggctttctttgtg (Leu) 5′ ttcctaca ggaagcaagt agtaattgat ggagaaacct gtctcttggaSEQ ID NO: 6 tattctcgac acagcaggtc Tagaggagta cagtgcaatg agggaccagtacatgaggac tggggagggc tttctttgtg (His) 5′ ttcctaca ggaagcaagt agtaattgatggagaaacct gtctcttgga SEQ ID NO: 7 tattctcgac acagcaggtc aTgaggagtacagtgcaatg agggaccagt acatgaggac tggggagggc tttctttgtg (His) 5′ ttcctacaggaagcaagt agtaattgat ggagaaacct gtctcttgga SEQ ID NO: 8 tattctcgacacagcaggtc aCgaggagta cagtgcaatg agggaccagt acatgaggac tggggagggctttctttgtg

[0185] 0.3 μg each of the DNAs comprising the nucleotide sequences setforth in SEQ ID NOs: 1, 4, 5, and 6 in the sequence listing were addedas dummy DNAs into blood-collecting tubes (containing heparin sodium)and dried. These dummy DNAs were modified at the 5′-end with biotinprior to use. Blood samples (3 ml each) collected from a healthy normalsubject were placed in blood-collecting tubes containing dummy DNAs andan ordinary blood-collecting tube (containing no dummy DNA), and gentlystirred using a rotator. After being left to stand at room temperaturefor 1 h, aliquots of the blood (0.1 ml each) were withdrawn from theblood-collecting tubes and placed in microtubes, and DNAs were extractedusing a DNA extraction kit (Gen Torukun™, Takarashuzo). The polymerasechain reaction (PCR) was performed using as the template DNAs thusextracted in the following reaction system under the conditionsdescribed below. KOD-dash DNA polymerase (Toyobo) and a10-fold-concentrated buffer attached to the kit were used in the PCR.PCR was performed by repeating 25 cycles of “94° C. 30 s, 52° C. 10 s,and 74° C. 30 s”. PCR Reaction system Reaction solution composition (μl)Attached 10-fold concentrated 5 buffer 2 mM dNTP 5 Primer F (20pmol/μl)* 1 Primer-D (20 pmol/μl)* 1 Template DNA (50 ng/μl) 0.5KOD-dash DNA polymerase 0.5 Sterilized distilled water 37 Total 50

[0186] As a result of PCR, in every case in which a DNA extracted from ablood sample collected into a blood-collecting tube was used as atemplate, the amplification of a 128 bp DNA fragment was confirmed asshown in FIG. 1. Nucleotide sequences of DNA fragments thus amplifiedwere analyzed using primer F and a BigDye terminator cycle sequenceready reaction kit (Perkin-Elmer) with an ABI 310 genetic analyzer(Perkin-Elmer). As shown in FIG. 2, the nucleotide sequence of thefragment amplified using as a template, DNA derived from blood collectedin the ordinary blood-collecting tube was completely identical to thatset forth in SEQ ID NO: 1 from 30 nucleotides downstream of the primerwhere the analytical results are apparent (FIG. 2). In contrast, thenucleotide sequence of the fragment amplified using as a template DNAderived from blood collected in blood-collecting tubes containing dummyDNAs, had intermingled signals at the site where the 4 types of dummiesdiffered (the site encoding the 61^(st) codon of the Ras protein), whichmade accurate reading of the nucleotide sequence impossible (FIG. 3).Namely, the sequence CAA in the healthy normal subject was erroneouslyread as CTA. Since the dummy DNAs have four different codons CAA, CTA,CCA, and CGA, it is clear that the four types of peaks were intermingledat the second nucleotide position of the codon as theoreticallypredicted. Thus, it is clear that the analysis of ras gene using a bloodsample from a subject has been interfered with and locked by using ablood sample-collecting tube containing dummy DNAs.

EXAMPLE 2 Unlocking of Genome Information

[0187] Next, it was confirmed that the unlocking can be done and theoriginal information can be read by removing the interfering factor(dummy DNA) from the information on the nucleotide sequence that hasbeen locked by the interference. Since dummy DNAs are modified withbiotin, they can be removed using magnetic beads binding streptavidin.

[0188] Magnetic beads bound to streptavidin (Dynabeads M-280Streptavidin (DYNAL)) (0.15 ml) were transferred into a microtube, andseparated from the supernatant on a magnet stand. The supernatant wasdiscarded, and, after washing beads with B & W buffer (10 mM Tris-HCl,pH 7.5, 1 mM EDTA, 2 M NaCl), the DNA (50 μl, ca 0.3 μg) derived fromthe blood in the blood-collecting tube containing B & W buffer (50 μl)and dummy DNA was mixed with the magnetic beads. After the resultingmixture was left to stand at room temperature for 15 min, thesupernatant was separated from beads on a magnetic stand and recovered.PCR was performed similarly as in Example 1 using as a template DNAcontained in the supernatant, and the nucleotide sequence of the DNAfragment thus amplified was analyzed with an ABI 310 genetic analyzer(Perkin-Elmer) using primer F and a Big Dye terminator cycle sequenceready reaction kit (Perkin-Elmer). The results are shown in FIG. 4.

[0189] Results show that streptavidin bound to magnetic beads binds tobiotinized dummy DNA to almost completely trap the dummy DNA onto thebead surface so that intermingled signals observed in the locked stateare completely absent. That is, the supernatant contained only DNAderived from the subject's blood so that the signal of CAA (the partencoding the 61^(st) codon of Ras protein), the sequence in the ras geneof the healthy normal subject, could be confirmed. These results provedthat it was actually possible to unlock locked genomic information byperforming the specific method for removing the chemically modifieddummy DNA.

EXAMPLE 3 Locking of Information Using Eight Different Types of DummyDNAs and the Influence of the Amount of Dummy DNA

[0190] Next, types of dummy DNA added to the blood-collecting tube wereincreased, and the locking was conducted using all the eight types.Using the same method as in Example 1, blood was collected into ablood-collecting tube containing eight types of dummy DNAs (0.3 μg each)to extract DNA. In this case, however, the amount ratios of dummy DNAsto be added into the blood-collecting tube were varied as shown in Table1, and changes in signals were observed.

[0191] The results are as shown in FIG. 5. In the case where DNAs setforth in SEQ ID NOs: 2 and 4 were added 3.5-folds more than other DNAsequences (FIGS. 6 and 7 respectively) or in an equal amount (FIG. 5),signals were all judged as CAA, the signal of the wild type. In spite ofthe presence of DNAs set forth in SEQ ID NO: 2 (nucleotides 68 to 70:AAA) and SEQ ID NO: 4 (nucleotides 68 to 70: CGA) in an amount that is3.5-folds more than other DNA sequences, all of them were detected asthe wild type sequence. That is, even in the case where a particular DNAsequence other than the wild type DNA is intermingled in a 3.5-foldexcess, the detected sequences were all that of the wild type (CAA) ,similarly as in the case of mixing an equal amount of the respectivedummy DNA.

[0192] This is thought to be due to the fact that, with the increase inthe types of dummy DNA, among the respective nucleotides at the 68^(th),69^(th), and 70^(th) positions, the signal of the nucleotide with thestrongest presence was emitted more strongly than others (cf. Table 2).Furthermore, the ras gene derived from blood in this Example is of thewild type (SEQ ID NO: 1), while the respective dummy DNAs are present ina large excess over the ras gene derived from the blood sample, andtherefore, the sequence (CAA) obtained by the nucleotide sequenceanalysis is likely to be derived from dummy DNAs, and not from theblood. From the above-described facts, it is clear that if dummy DNAshaving a wild-type sequence were present in excessive amounts, theywould function to cover up mutant sequences. That is, even if there wasa mutation in DNA derived from blood, the predominance of an excessiveamount of dummy DNAs having a wild-type sequence, would lead to a moresecure locking of the genomic information to an extent that makes itdifficult to confirm even whether the genomic information is locked ornot. TABLE 1 SEQ ID NOs FIGS. 1 2 3 4 5 6 7 8 1 1 1 1 1 1 1 1 1 3.5 1 11 1 1 1 1 1 1 3.5 1 1 1 1

[0193] TABLE 2 Nucleotide composition (%) Nucleotide G C A T 68^(th)nucleotide 12.5 75.0 12.5 0 69^(th) nucleotide 12.5 12.5 62.5 12.570^(th) nucleotide 0 12.5 75.0 12.5

EXAMPLE 4 Locking and Unlocking of Information Using Dummy DNAChemically Modified With a Substance Other Than Biotin (in the Case ofUsing Digoxigenin)

[0194] The information of c-Ki-ras gene was locked similarly as inExample 1 using a dummy DNA modified at the 5′-end thereof withdigoxigenin. Into a blood-collecting tube, the wild type DNA (0.3 μg)(SEQ ID NO: 1) and a mixture of equal amounts of dummy DNAs (SEQ ID NOs:4, 5, 6, and 7) were added in an amount that was 3-folds the amount ofwild type DNA (1 μg) to lock the wild type genetic information. Usingthe resulting mixture as a template, PCR was carried out using primers Fand D by the same method as in Example 1. Using the DNA fragment thusamplified as a template, the nucleotide sequence thereof was analyzedusing primer D by the same method as in Example 1, and, as a result, thesignal interference as shown in FIG. 8 was confirmed, and the 69^(th)nucleotide could not be determined.

[0195] Then, the anti-digoxigenin antibody (Boehringer-Manheim) (20 μl)was added to the above-described mixture, followed by protein GSepharose (Amersham-Pharmacia) (ca 30 μg). The resulting mixture wasincubated at 37° C. for 10 min and then centrifuged at 3,000×g for 1 minto precipitate and remove the dummy DNA as a complex with the antibodyand protein G Sepharose. Then, using the supernatant thereof (1 μl) as atemplate, PCR was performed by the same method as in Example 1. Usingthe sample (3 μl) after PCR as a template, and primer F, the nucleotidesequence of the sample was analyzed by the same method as in Example 1.As a result, as shown in FIG. 9, the signal interference of the 69^(th)nucleotide disappeared, and the right nucleotide A (as is in the wildtype DNA) became clearly readable. That is, it was proved that thechemically modified dummy DNA was specifically recognized by theantibody, an affinity substance for the modified site, and the dummy DNAwas almost completely removed as a precipitate by protein G Sepharose,which has affinity towards the antibody.

EXAMPLE 5

[0196] Next, the unlocking of wild type DNA (SEQ ID NO: 1) that had beenlocked using dummy DNAs having single nucleotide substitutions in thewild type DNA sequence was conducted. As dummy DNA, an equimolar mixtureof the following sequences was used. Mutant portions (portions differentfrom the wild type) of the respective dummy DNAs were all described incapital letters, and the substituted portions to influence thespecificity of the key primers in this Example were underlined. SEQ IDNO: 11 (SEQ ID NO: 4 having two single nucleotide substituted portions)ttcctacagg aagcaagtaA taattgatgg agaaacctgt ctcttggata ttctcgacacagcaggtcGa gaggagtaca gtgcaatgag ggaccagtac atgaggacAg gggagggctttctttgtg

[0197] SEQ ID NO: 12 (SEQ ID NO: 4 having two single nucleotidesubstituted portions) ttcctacagg aagcaagtaC taattgatgg agaaacctgtctcttggata ttctcgacac agcaggtcGa gaggagtaca gtgcaatgag ggaccagtacatgaggacCg gggagggctt tctttgtg

[0198] SEQ ID NO: 13 (SEQ ID NO: 4 having two single nucleotidesubstituted portions) ttcctacagg aagcaagtaC taattgatgg agaaacctgtctcttggata ttctcgacac agcaggtcGa gaggagtaca gtgcaatgag ggaccagtacatgaggacAg gggagggctt tctttgtg

[0199] SEQ ID NO: 14 (SEQ ID NO: 6 having two single nucleotidesubstituted portions) ttcctacagg aagcaagtaA taattgatgg agaaacctgtctcttggata ttctcgacac agcaggtcTa gaggagtaca gtgcaatgag ggaccagtacatgaggacAg gggagggctt tctttgtg

[0200] SEQ ID NO: 15 (SEQ ID NO: 6 having two single nucleotidesubstituted portions) ttcctacagg aagcaagtaC taattgatgg agaaacctgtctcttggata ttctcgacac agcaggtcTa gaggagtacagtgcaatgag ggaccagtac atgaggacCg gggagggctt tctttgtg

[0201] SEQ ID NO: 16 (SEQ ID NO: 6 having two single nucleotidesubstituted portions) ttcctacagg aagcaagtaC taattgatgg agaaacctgtctcttggata ttctcgacac agcaggtcTa gaggagtaca gtgcaatgag ggaccagtacatgaggacAg gggagggctt tctttgtg

[0202] SEQ ID NO: 17 (SEQ ID NO: 5 having two single nucleotidesubstituted portions) ttcctacagg aagcaagtaA taattgatgg agaaacctgtctcttggata ttctcgacac agcaggtcCa gaggagtaca gtgcaatgag ggaccagtacatgaggacAg gggagggctt tctttgtg

[0203] SEQ ID NO: 18 (SEQ ID NO: 5 having two single nucleotidesubstituted portions) ttcctacagg aagcaagtaC taattgatgg agaaacctgtctcttggata ttctcgacac aqcaggtcCa gaggagtaca gtgcaatgag ggaccagtacatgaggacCg gggagggctt tctttgtg

[0204] SEQ ID NO: 19 (SEQ ID NO: 5 having two single nucleotidesubstituted portions) ttcctacagg aagcaagtaC taattgatgg agaaacctgtctcttggata ttCtcgacac agcaggtcCa gaggagtaca gtgcaatgag ggaccagtacatgaggacAg gggagggctt tctttgtg

[0205] Using the wild type DNA (SEQ ID NO: 1) as a DNA derived from abiological sample, the locking was done by mixing with an equimolarmixture of dummy DNAs set forth in SEQ ID NOs: 11 through 19 at a molarratio of 1:3 (Example 4-1) or 1:9 (Example 4-2). In order to examinewhether the unlocking of a DNA sample locked in this state can besecurely carried out or not, amplification by PCR was conducted with a50-fold diluted DNA sample (1 μl, 7.1 fmol) that had been locked as atemplate using the key primers comprising the nucleotide sequences setforth in SEQ ID NOs: 9 and 10. Furthermore, a sample containing only thewild type DNA set forth in SEQ ID NO: 1 as a template in the same amountas in Example 4-1 and 4-2 (Comparative Example 4-0), and another samplecontaining only the dummy DNAs set forth in SEQ ID NOs: 11 through 19 inthe same amount as in Example 4-1 and 4-2 (Comparative Example 4-3) wereprepared, and PCR was performed similarly as in Examples.

[0206] The key primers (20 pmol) and 0.2 mM dNTP were added to the PCRsystem (50 μl), and as a thermostable DNA polymerase, Taq DNA polymerase(Sigma, 1 unit) was used. PCR was performed, after the treatment at 94°C. for 1 min, by 19 reaction cycles of “94° C. 30 s, 55° C. 30 s, and72° C. 1 min”. At the 10^(th), 13^(th), 16^(th), and 19^(th) cycle,samples (10 μl each) were withdrawn, and aliquots (3 μl each) weresubjected to 5% polyacrylamide gel electrophoresis for analysis (FIG.11).

[0207] As a result of electrophoresis, in the case of the ComparativeExample 4-0 in which only the wild type DNA served as a template, theamplification of the target DNA fragment could already be confirmed atthe 10^(th) cycle of PCR (FIG. 11, lane 2), the concentration of theamplified DNA having increased with the increase in the number of cycles(FIG. 11, lanes 3 to 5). In contrast to this, in the case where amixture of dummy DNAs combined with the wild type DNA in a ratio of 3:1(the concentration of the wild type DNA was ⅓ of that in ComparativeExample 4-0) was used as a template, a slight amplification could bebarely confirmed at the 10^(th) cycle (FIG. 11, lane 6) with theamplifications at relatively low concentrations compared to that ofComparative Example 4-0 even at the 13^(th) and 16^(th) cycles (FIG. 11,lanes 7 to 9). Furthermore, in the case where the dummy DNAs were mixedwith the wild type DNA in a ratio of 9:1 (the concentration of the wildtype DNA was {fraction (1/9)} of that in Comparative Example 4-0)amplifications of relatively low concentrations compared to that ofComparative Example 4-0 were observed throughout all cycles with theamplification levels being lower than in Example 4-1 (FIG. 11, lanes 10to 13). Moreover, in the case where only the dummy DNAs were mixed toserve as a template (Comparative Example 4-3), the amplification oftarget DNA fragment was not observed (FIG. 11, lanes 14 to 17) at all.

[0208] From the aforementioned results, a DNA amplified using the keyprimers is thought to be comprised solely of the wild type DNA set forthin SEQ ID NO: 1. The basis for this conclusion are the facts that theconcentration of fragments amplified by PCR were dependent on theconcentration of the wild type DNA contained in the original template,and that there was no amplification in PCR performed solely using thedummy DNAs as template.

[0209] Furthermore, DNA fragments amplified by 19 cycles of PCR in therespective Examples and the Comparative Example 4-0 were sequenced toexamine whether they actually have the wild type sequence or not. Asshown in panels A and B in FIG. 12, it is natural that fragmentsamplified with a template solely comprising the wild type DNA(Comparative Example 4-0) show the wild type sequence. However, it wasfound that, as shown in panels B and C as well as panels D and E in FIG.12, when DNAs were amplified using templates comprising the wild typeDNA mixed with a 3-fold and 9-fold excessive amounts of the dummy DNAs(Examples 4-1 and 4-2, respectively), DNA having the wild typenucleotide sequence was amplified similarly as in the ComparativeExample 4-0. Thus, the results of sequencing proved a possibility thatonly the wild type DNA is selectively amplified using the key primersand that the information is actually unlocked using the key primers.

Industrial Applicability

[0210] The present invention makes it possible to actively prevent theanalysis of personal information that the subject does not intend toperform. Despite the fact that biological samples represented by bloodare the source of important personal information, at present, thesecurity thereof has been entrusted to only protection by operationrules and morals. That is, it can be said that, although personalinformation is an individual's own information, the management of theinformation has been entirely entrusted to strangers. The presentinvention makes it possible to control the security of personalinformation actively by oneself. A method for technically as well assecurely protecting information that can be obtained from biologicalsamples has been achieved for the first time by the present invention.

[0211] With the arrival of the postgenomic era, the speed of geneticinformation analysis is expected to dramatically increase. With theprogress of genetic information analysis, the importance of geneticinformation will become increasingly enhanced. According to the presentinvention, the analysis of personal information that the person does notwish to analyze can be securely prevented so as to enable themaintenance of the security of information.

1 33 1 128 DNA Homo sapiens portion of c-Ki-ras proto-oncogene of normalhealthy subject (wild type(WT)) 1 ttcctacagg aagcaagtag taattgatggagaaacctgt ctcttggata ttctcgacac 60 agcaggtcaa gaggagtaca gtgcaatgagggaccagtac atgaggactg gggagggctt 120 tctttgtg 128 2 128 DNA ArtificialSequence Description of Artificial Sequencedummy DNA, 61st codon Lys 2ttcctacagg aagcaagtag taattgatgg agaaacctgt ctcttggata ttctcgacac 60agcaggtaaa gaggagtaca gtgcaatgag ggaccagtac atgaggactg gggagggctt 120tctttgtg 128 3 128 DNA Artificial Sequence Description of ArtificialSequencedummy DNA, 61st codon Glu 3 ttcctacagg aagcaagtag taattgatggagaaacctgt ctcttggata ttctcgacac 60 agcaggtgaa gaggagtaca gtgcaatgagggaccagtac atgaggactg gggagggctt 120 tctttgtg 128 4 128 DNA ArtificialSequence Description of Artificial Sequencedummy DNA, 61st codon Arg 4ttcctacagg aagcaagtag taattgatgg agaaacctgt ctcttggata ttctcgacac 60agcaggtcga gaggagtaca gtgcaatgag ggaccagtac atgaggactg gggagggctt 120tctttgtg 128 5 128 DNA Artificial Sequence Description of ArtificialSequencedummy DNA, 61st codon Pro 5 ttcctacagg aagcaagtag taattgatggagaaacctgt ctcttggata ttctcgacac 60 agcaggtcca gaggagtaca gtgcaatgagggaccagtac atgaggactg gggagggctt 120 tctttgtg 128 6 128 DNA ArtificialSequence Description of Artificial Sequencedummy DNA, 61st codon Leu 6ttcctacagg aagcaagtag taattgatgg agaaacctgt ctcttggata ttctcgacac 60agcaggtcta gaggagtaca gtgcaatgag ggaccagtac atgaggactg gggagggctt 120tctttgtg 128 7 128 DNA Artificial Sequence Description of ArtificialSequencedummy DNA, 61st codon His 7 ttcctacagg aagcaagtag taattgatggagaaacctgt ctcttggata ttctcgacac 60 agcaggtcat gaggagtaca gtgcaatgagggaccagtac atgaggactg gggagggctt 120 tctttgtg 128 8 128 DNA ArtificialSequence Description of Artificial Sequencedummy DNA, 61st codon His 8ttcctacagg aagcaagtag taattgatgg agaaacctgt ctcttggata ttctcgacac 60agcaggtcac gaggagtaca gtgcaatgag ggaccagtac atgaggactg gggagggctt 120tctttgtg 128 9 20 DNA Artificial Sequence Description of ArtificialSequencekey primer, Primer F 9 ttcctacagg aagcaagtag 20 10 20 DNAArtificial Sequence Description of Artificial Sequencekey primer, PrimerD 10 cacaaagaaa gccctcccca 20 11 128 DNA Artificial Sequence Descriptionof Artificial Sequencedummy DNA having two single nucleotide substitutedportions 11 ttcctacagg aagcaagtaa taattgatgg agaaacctgt ctcttggatattctcgacac 60 agcaggtcga gaggagtaca gtgcaatgag ggaccagtac atgaggacaggggagggctt 120 tctttgtg 128 12 128 DNA Artificial Sequence Descriptionof Artificial Sequencedummy DNA having two single nucleotide substitutedportions 12 ttcctacagg aagcaagtac taattgatgg agaaacctgt ctcttggatattctcgacac 60 agcaggtcga gaggagtaca gtgcaatgag ggaccagtac atgaggaccggggagggctt 120 tctttgtg 128 13 128 DNA Artificial Sequence Descriptionof Artificial Sequencedummy DNA having two single nucleotide substitutedportions 13 ttcctacagg aagcaagtac taattgatgg agaaacctgt ctcttggatattctcgacac 60 agcaggtcga gaggagtaca gtgcaatgag ggaccagtac atgaggacaggggagggctt 120 tctttgtg 128 14 128 DNA Artificial Sequence Descriptionof Artificial Sequencedummy DNA having two single nucleotide substitutedportions 14 ttcctacagg aagcaagtaa taattgatgg agaaacctgt ctcttggatattctcgacac 60 agcaggtcta gaggagtaca gtgcaatgag ggaccagtac atgaggacaggggagggctt 120 tctttgtg 128 15 128 DNA Artificial Sequence Descriptionof Artificial Sequencedummy DNA having two single nucleotide substitutedportions 15 ttcctacagg aagcaagtac taattgatgg agaaacctgt ctcttggatattctcgacac 60 agcaggtcta gaggagtaca gtgcaatgag ggaccagtac atgaggaccggggagggctt 120 tctttgtg 128 16 128 DNA Artificial Sequence Descriptionof Artificial Sequencedummy DNA having two single nucleotide substitutedportions 16 ttcctacagg aagcaagtac taattgatgg agaaacctgt ctcttggatattctcgacac 60 agcaggtcta gaggagtaca gtgcaatgag ggaccagtac atgaggacaggggagggctt 120 tctttgtg 128 17 128 DNA Artificial Sequence Descriptionof Artificial Sequencedummy DNA having two single nucleotide substitutedportions 17 ttcctacagg aagcaagtaa taattgatgg agaaacctgt ctcttggatattctcgacac 60 agcaggtcca gaggagtaca gtgcaatgag ggaccagtac atgaggacaggggagggctt 120 tctttgtg 128 18 128 DNA Artificial Sequence Descriptionof Artificial Sequencedummy DNA having two single nucleotide substitutedportions 18 ttcctacagg aagcaagtac taattgatgg agaaacctgt ctcttggatattctcgacac 60 agcaggtcca gaggagtaca gtgcaatgag ggaccagtac atgaggaccggggagggctt 120 tctttgtg 128 19 128 DNA Artificial Sequence Descriptionof Artificial Sequencedummy DNA having two single nucleotide substitutedportions 19 ttcctacagg aagcaagtac taattgatgg agaaacctgt ctcttggatattctcgacac 60 agcaggtcca gaggagtaca gtgcaatgag ggaccagtac atgaggacaggggagggctt 120 tctttgtg 128 20 134 DNA Artificial Sequence Descriptionof Artificial Sequenceanalytical results of nucleotide sequence of PCRfragment amplified using primer F, DNA from blood containing no dummyDNA 20 tantgnggag acctgtctct tggtattctc gacacagcag gtcaagagga gtacagtgca60 atgagggacc agtacatgag gactggggag ggctttcttt gtgaacctgc aggcatgcaa 120gcttggcgta atca 134 21 134 DNA Artificial Sequence Description ofArtificial Sequenceanalytical results of nucleotide sequence of PCRfragment amplified using primer F, DNA from blood containing dummy DNA21 tantgnggag ancctgtctc ttggaattct cgacacagca ggtctagagg agtacagtgc 60aatgagggac cagtacatga ggactgggga gggctttctt tgtgaacctg caggcatgca 120agcttggcgt aatc 134 22 133 DNA Artificial Sequence Description ofArtificial Sequenceanalytical results of nucleotide sequence of PCRfragment amplified using primer F, DNA from blood containing dummy DNAremoved by streptavidin-bound magnetic beads 22 tantgtggag anctgtctcttggaattctc gacacagcag gtcaagagga gtacagtgca 60 atgagggacc agtacatgaggactggggag ggctttcttt gtgaacctgc aggcatgcaa 120 gcttggcgta atc 133 23136 DNA Artificial Sequence Description of Artificial Sequenceanalyticalresults of nucleotide sequence of PCR fragment amplified using primer F,DNA from blood containing dummy DNA 23 tgnggagaac ctgtctcttg gtattctcgacacagcaggt caagaggagt acagtgcaat 60 gagggaccag tacatgagga ctggggagggctttctttgt gaacctgcag gcatgcaagc 120 ttggcgtaat catggt 136 24 135 DNAArtificial Sequence Description of Artificial Sequenceanalytical resultsof nucleotide sequence of PCR fragment amplified using primer F, DNAfrom blood containing dummy DNA 24 tgnggagaac tgtctcttgg tattctcgaacagcaggtca agaggagtac agtgcaatga 60 gggaccagta catgaggact ggggagggctttctttgtga acctgcaggc atgcaagctt 120 ggcgtaatca tggtc 135 25 131 DNAArtificial Sequence Description of Artificial Sequenceanalytical resultsof nucleotide sequence of PCR fragment amplified using primer F, DNAfrom blood containing dummy DNA 25 tatggagaag anctgctttg gaattctcgaacagcaggtc aagaggagta cagtgcaatg 60 agggaccagt acatgaggac tggggagggctttctttgtg aacctgcagg catgcaagct 120 tggcgtaatc a 131 26 139 DNAArtificial Sequence Description of Artificial Sequenceanalytical resultsof nucleotide sequence of PCR fragment amplified using primer D, DNAfrom blood containing dummy DNA 26 gnctcatgtc tggtccctca ttgcactgtactcctctnga cctgctgtgt ccgagaatat 60 ccaagagaca ggtttctcca tcaattactacttgcttcct gtaggaagcc gctanngcca 120 tcancactcc ccngcttgc 139 27 134 DNAArtificial Sequence Description of Artificial Sequenceanalytical resultsof nucleotide sequence of PCR fragment amplified using primer F, DNAfrom blood containing dummy DNA removed by protein G-Sepharose 27tgnggagacc tgtctcttgg aattctcgaa cagcaggtca agaggagtac agtgcaatga 60gggaccagta catgaggact ggggagggct ttctttgtga acctgcaggc atgcaagctt 120ggcgtaatca tggt 134 28 29 DNA Artificial Sequence Description ofArtificial Sequenceoriginal DNA derived from biological sample withoutmismatched base bair 28 catcaattac tactggcttc cagtaggaa 29 29 29 DNAArtificial Sequence Description of Artificial Sequencedummy DNA-1 withmismatched base pair 29 catcaattag tactggcttc cagtaggaa 29 30 29 DNAArtificial Sequence Description of Artificial Sequencedummy DNA-2 withmismatched base pair 30 catcaattaa tactggcttc cagtaggaa 29 31 29 DNAArtificial Sequence Description of Artificial Sequencedummy DNA-3 withmismatched base pair 31 catcaattat tactggcttc cagtaggaa 29 32 12 DNAArtificial Sequence Description of Artificial Sequenceanalytical resultof nucleotide sequence of selective amplification of wild type DNA usingkey primer 32 gcaggtcaag ag 12 33 12 DNA Artificial Sequence Descriptionof Artificial Sequenceanalytical result of nucleotide sequence ofselective amplification of wild type DNA using key primer 33 ctcttgacctgc 12

1. A method for protecting personal information obtained by analyzing abiological sample, wherein said method comprises adding to thebiological sample, a component that obstructs the analysis of anothercomponent that provides personal information to be protected.
 2. Themethod according to claim 1, wherein said personal information to beprotected is genetic information.
 3. The method according to claim 2,wherein said component that provides genetic information is a nucleicacid or a protein.
 4. The method according to claim 3, wherein saidnucleic acid is genome or mRNA.
 5. The method according to claim 4,wherein said component obstructing analysis is a DNA comprising a regionhaving a nucleotide sequence that provides personal information.
 6. Themethod according to claim 5, wherein said nucleotide sequence thatprovides personal information contains a mutation.
 7. The methodaccording to claim 4, wherein said component obstructing analysis is atleast one of the DNA analysis obstructers selected from the groupconsisting of: (a) a random primer, (b) an inhibitor of theDNA-polymerase reaction, (c) an inhibitor of nucleic acid synthesis, and(d) a nuclease.
 8. A method for analyzing personal information protectedby the method according to claim 1, wherein said method comprises thestep of removing the obstruction of the component that was added toobstruct the analysis.
 9. The method according to claim 8, wherein saidobstructing component is DNA, and wherein the method comprises the stepof removing the obstruction of the DNA by selective separation,decomposition, or modification thereof.
 10. The method according toclaim 9, wherein the method comprises the step of selectively separatingsaid DNA by the affinity binding to a tag added in advance to the DNA.11. The method according to claim 10, wherein said tag is an affinitybinding substance and/or an artificially added nucleotide sequence. 12.The method according to claim 9, wherein said obstructing component isDNA comprising a restriction enzyme recognition sequence that is notpresent in the nucleotide sequence to be analyzed, and wherein saidmethod comprises the step of removing the obstruction by reacting with arestriction enzyme to selectively decompose the DNA.
 13. The methodaccording to claim 8, wherein said method comprises the steps of: (a)adding to a biological sample a DNA comprising (i) a nucleotide sequencethat provides personal information and (ii) a mutation as the componentthat obstructs the analysis, (b) analyzing the nucleotide sequence thatprovides personal information of a nucleic acid contained in saidbiological sample using a primer and/or probe, wherein said primerand/or probe is capable of hybridizing to the nucleic acid derived fromthe biological sample, but the hybridization to the DNA added in step(a) is inhibited due to the mutation contained in said DNA, and (c)analyzing personal information contained in the nucleic acid derivedfrom the biological sample using the hybridization level of said probeand/or primer as an index.
 14. A kit for analyzing protected personalinformation, which comprises a means for removing the obstructing actionof the component added to obstruct the analysis.
 15. A biologicalsample-collecting vessel for protecting personal information obtained byanalyzing a biological sample, wherein said vessel is filled in advancewith a component that obstructs the analysis of another component thatprovides the personal information to be protected.
 16. The vesselaccording to claim 15 provided with a means for indicating that theanalysis of the component that provides personal information to beprotected has been obstructed.
 17. The vessel according to claim 15further provided with a means for indicating information necessary forremoving said obstruction.
 18. The vessel according to claim 17, whereinsaid indication has been encoded.
 19. A database that connects (a)biological sample-collecting vessels for protecting personal informationthat can be obtained by analyzing a biological sample, wherein thevessels are filled in advance with a component that obstructs theanalysis of another component that provides personal information to beprotected, and (b) a means necessary for removing the influence of saidobstructing component for each of the vessels.
 20. A method forprotecting personal information, wherein the method comprises the stepsof: (1) connecting (a) biological sample-collecting vessels forprotecting personal information that can be obtained by analyzing abiological sample, wherein the vessels are filled in advance with acomponent that obstructs the analysis of another component that providespersonal information to be protected, with (b) a means necessary forremoving the influence of said obstructing component for each of thevessels, and (2) disclosing, according to a request from an individualwho requires analysis, a means necessary for removing the influence ofsaid obstructing component for a specific vessel.
 21. A sample-analyzingdevice provided with the following means: a) a means for reading anindication on a biological sample-collecting vessel that (a) is equippedwith a means for indicating information capable of specifying thevessel, and (b) is a biological sample-collecting vessel for protectingpersonal information obtained by analyzing a biological sample, whereinsaid vessel is filled in advance with a component that obstructs theanalysis of another component that provides personal information to beprotected, b) a means for disclosing a means necessary for removing theinfluence of an obstructing component contained in said vessel byinquiring the database according to claim 19 about information capableof specifying the vessel, c) a means for implementing the meansdisclosed by the means of b) that is necessary for removing theobstruction, and d) a means for analyzing the biological sample.
 22. Thedevice according to claim 21, which comprises inquiring the databaseaccording to claim 19 about information capable of specifying a vesselvia a network.
 23. A test sample-analyzing device equipped with thefollowing means: a) a means for reading an indication on a biologicalsample-collecting vessel equipped with a means for indicatinginformation necessary for removing the influence of an obstructingmeans, wherein said vessel for protecting personal information that canbe obtained by analyzing a biological sample has been filled in advancewith a component that obstructs the analysis of another component thatprovides personal information to be protected, b) a means forimplementing a means necessary for removing the obstruction based oninformation read in step a), and c) a means for analyzing the testsample.
 24. The analytical device according to claim 23, which comprisesa means for decoding the encoded information necessary for removing theinfluence of said obstruction means.
 25. The analytical device accordingto claim 24 comprising a means for inquiring about information necessaryfor the decoding via a network.
 26. A method for analyzing a biologicalsample, wherein the method comprises: a) reading an indication on avessel for collecting a biological sample equipped with a means forindicating information capable of specifying said vessel for protectingpersonal information obtained by analyzing a biological sample, whereinsaid vessel has been filled in advance with a component that obstructsthe analysis of another component that provides personal information tobe protected, b) disclosing a means necessary for removing the influenceof a obstructing component contained in said vessel by inquiring thedatabase according to claim 19 about information capable of specifyingthe vessel, c) implementing the means necessary for removing theobstruction based on the information read in step b), and d) analyzingthe sample.
 27. A method for analyzing a biological sample, wherein themethod comprises: a) reading an indication on a biologicalsample-collecting vessel equipped with a means for indicatinginformation necessary for removing the influence of an obstructingmeans, wherein said vessel for protecting the personal informationobtained by analyzing said biological sample has been filled in advancewith a component that obstructs the analysis of a component thatprovides the personal information to be protected, b) implementing ameans necessary for removing the obstruction based on the informationread in step a), and c) analyzing the sample.